R-X-FIX EXTERNAL FIXATOR

FDA 510(k)

FDA Class 2 ·Orthopedic

THE RINSPIRATOR, MODELS FG09770, FG08776, FG08777, FG08910

FDA 510(k)

FDA Class 2 ·Cardiovascular

SILVERHAWK-R PERIPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE

FDA 510(k)

FDA Class 2 ·Cardiovascular

SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550,04800, 05200, 02406, 04706, 04300

FDA 510(k)

FDA Class 2 ·Cardiovascular

PROSTATE PROBE SURFACE COIL, CATALOG #BPX-15

FDA 510(k)

FDA Class 2 ·Radiology

CLEARFIL AP-X AND LINER BOND 2

FDA 510(k)

FDA Class 2 ·Dental

MRINNERVU(R) ENDORECTAL PROSTATE COIL BPX-15

FDA 510(k)

FDA Class 2 ·Radiology

MEGAVISION CPX, MEGAVISION FA, MODEL I AND II

FDA 510(k)

FDA Class 2 ·Ophthalmic

Electric Wheelchair, Model: 9000N

FDA 510(k)

FDA Class 2 ·Physical Medicine

THE LUNG GYM (XLATOR AND NLATOR)

FDA 510(k)

FDA Class 2 ·Anesthesiology

Impress SFS System

FDA 510(k)

FDA Class 2 ·Orthopedic

Stealth-Midas MR8 System

FDA 510(k)

FDA Class 2 ·Neurology

Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System Accessories

FDA 510(k)

FDA Class 2 ·Neurology

ULTRATONE 8+ & 20

FDA 510(k)

FDA Class 2 ·Physical Medicine

FINGERTIP PULSE OXIMETER, MODEL MD300CA ND300CA

FDA 510(k)

FDA Class 2 ·Cardiovascular

CYTOSCAN

FDA 510(k)

FDA Class 2 ·Hematology

MOBICATH TRANSSEPTAL NEEDLE

FDA 510(k)

FDA Class 2 ·Cardiovascular

Nexta PEEK Hammertoe Correction System

FDA 510(k)

FDA Class 2 ·Orthopedic

PHOTEX DIODE LASER SERIES, MODELS 980, 810 AND 940

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BARD PTV DILATATION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular